N/A
Completed N=283
Clinical Evaluation of Two Approved Contact Lenses
Visual Acuity
Source: ClinicalTrials.gov NCT02759692 ↗
Enrolled (actual)
283
Serious AEs
0.4%
Results posted
Aug 2017
Primary outcomePrimary: Overall Comfort — 72.5; 63.8 Units on a Scale
Summary
Adaptive, randomized, subject-masked, dispensing study to evaluate the short-term, clinical performance of two FDA-approved contact lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort |
72.5; 63.8 | — |
| PRIMARY Overall Quality of Vision |
67.5; 62.1 | — |
| SECONDARY Individual Patient Reported Outcomes (Items 1-5) |
75.1; 65.1; 68.5; 58.1; 75; 61.1 | — |
| SECONDARY Individual Patient Reported Outcomes (Items 6-10) |
79.3; 69.8; 81.6; 69.8; 78.3; 66.9 | — |
| SECONDARY Individual Patient Reported Outcomes (Items 11-14) |
91.3; 90.2; 85.8; 77.3; 89.9; 84.2 | — |
| SECONDARY Individual Patient Reported Outcomes (Items 15-17) |
85.6; 74.5; 83.3; 73.8; 81.5; 70.8 | — |
Eligibility Criteria
Inclusion Criteria
- The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must be between (and including) 18 and 39 years of age.
- The subject must be an adapted wearer of spherical soft contact lenses in both eyes. That is, the subject must wear their habitual lenses at least five (5) days per week and eight (8) hours per day, worn for at least 30 days immediately preceding the study.
- Have vertex-corrected distance refraction that allows a plano over-refraction with the available contact lens powers of -1.00 to -6.00 Diopters (D) in each eye.
- Have refractive astigmatism, if present, of less than or equal to 1.00 D in each eye.
- The subject must have best corrected visual acuity of 20/25 or better in each eye.
Exclusion Criteria
- Currently pregnant or breastfeeding (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any autoimmune disease or use of medication, which may interfere with contact lens wear.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
- Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.).
- Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Monovision, multi-focal, toric, or extended wear contact lens correction.
- Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- History of binocular vision abnormality or strabismus that is likely to affect successful contact lens wear.
- Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
Data sourced from ClinicalTrials.gov (NCT02759692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.